General Information

Clindamycin Impurities and Clindamycin

Daicel Pharma synthesizes Clindamycin impurities of exceptional quality, such as Clindamycin Imp C, Clindamycin impurity D, Clindamycin impurity E, Clindamycin Impurity F, Clindamycin phosphate sulfoxide, Isopropylidene Clindamycin, and Isopropylidene Clindamycin Phosphate. These impurities are crucial to assess the purity, reliability, and safety of an active pharmaceutical ingredient, Clindamycin. Besides, Daicel Pharma provides custom synthesis of Clindamycin impurities to meet clients’ demands for global delivery.

Clindamycin [CAS: 18323-44-9] is an antibiotic and a lincomycin derivative. It has a broad spectrum of activity against various bacterial infections and is bacteriostatic.

Clindamycin: Use and Commercial Availability  

Clindamycin treats various infections, including septicemia, intra-abdominal infections, lower respiratory infections, gynecological infections, bone and joint infections, and skin and skin structure infections. It treats streptococcal pharyngitis, acne vulgaris, bacterial vaginosis, severe pelvic inflammatory disease, and certain types of pneumonia. Furthermore, Clindamycin shows effectiveness against conditions like babesiosis, anthrax, malaria, and uncomplicated skin and soft tissue infections, particularly those caused by methicillin-resistant Staphylococcus aureus (MRSA). Clindamycin can be administered orally, topically, or parenterally, depending on the type and severity of the infection. Various brand names, including Cleocin, Clindagel, Clindesse, Clindets, Evoclin, Veltin, Xaciato, etc., are available in different formulations.

Clindamycin Structure and Mechanism of Action

The chemical name of Clindamycin is Methyl 7-chloro-6,7,8-trideoxy-6-[[[(2S,4R)-1-methyl-4-propyl-2-pyrrolidinyl]carbonyl]amino]-1-thio-L-threo-α-D-galacto-octopyranoside. Its chemical formula is C₁₈H₃₃ClN₂O₅S, and its molecular weight is approximately 425.0 g/mol.

Clindamycin inhibits bacterial protein synthesis. It binds to the 23S RNA of the 50S subunit of the ribosome.

Clindamycin Impurities and Synthesis

Clindamycin is a commonly used antibiotic, and its impurities can arise from various sources, including the synthetic process¹, degradation during storage, and contaminants in raw materials. They affect the drug’s safety, efficacy, and quality. Therefore, it is necessary to identify and quantify these impurities through analytical testing and implement appropriate measures to control their levels. Common Clindamycin impurities include related substances, degradation products, and residual solvents. Analytical methods such as HPLC and LC help analyze and monitor these impurities.

Daicel Pharma offers a Certificate of Analysis (CoA) for Clindamycin impurity standards, such as Clindamycin Imp C, Clindamycin impurity D, Clindamycin impurity E, Clindamycin Impurity F, Clindamycin phosphate sulfoxide, Isopropylidene Clindamycin, and Isopropylidene Clindamycin Phosphate, generated from an analytical facility compliant with cGMP standards. The CoA includes a comprehensive characterization report comprising data from techniques like 1H NMR, 13C NMR, IR, MASS, and HPLC purity². Furthermore, on request, we give additional data like 13C-DEPT and CHN. Daicel Pharma can synthesize unknown Clindamycin impurities or degradation products. A complete characterization report accompanies every delivery.